Prophylactic Use of Levosimendan Versus Milrinone in Open Heart Surgery in Infants

Phase 2

• Conditions: Low Cardiac Output Syndrome
• Interventions: Drug: Levosimendan; Drug: Milrinone

• Registration Number: NCT00549107
• Lead Sponsor: Ludwig Boltzmann Gesellschaft

Brief Summary

Pediatric patients, especially infants undergoing open heart surgery have a predictable fall in cardiac index 6 to 18 hours after surgery, the so-called low cardiac output syndrome (LCOS). Patients, who have LCOS require more monitoring, more medication and a longer stay in intensive care unit. To prevent LCOS the phosphodiesterase inhibitor milrinone is routinely used during the first 24 hours after surgery. Levosimendan, a calcium- sensitizer improves cardiac muscle contractile force, vascular smooth muscle relaxation and coronary blood flow through calcium sensitization of the myocardial contractile filaments and opening of potassium channels without increasing oxygen consumption of the heart muscle cells. As the myocardium of infants is more calcium dependent than in later life, levosimendan should be of special benefit in this age group. The purpose of this study is to investigate whether levosimendan is superior to milrinone in preventing LCOS in infants after corrective open heart surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Status Verified: 2007-10
• Study First Submitted: 2007-10-24
• Study First Submitted QC: 2007-10-24
• Last Update Submitted: 2007-10-24
• Study First Posted: 2007-10-25
• Last Update Posted: 2007-10-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age younger than one year
• corrective open heart surgery with biventricular repair, except tetralogy of fallot

Exclusion Criteria

• Missing written consent of parents
• Weight less than 3 kg
• preoperative LCOS
• gestational age less than 36 weeks
• preexisting renal failure
• preexisting thrombopenia
• preoperative cardiopulmonary resuscitation
• preoperative use of milrinone or levosimendan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Levosimendan	-
2	Milrinone	-

Primary Outcome Measures

Name	Time	Method
Cardiac output measured by a transesophageal probe	48 hours

Secondary Outcome Measures

Name	Time	Method
Changes in mixed venous saturation	48 hours
Serum lactate levels	48 hours
Cardiac output and ventricular function assessed by echocardiography	48 hours
Mean arterial, left atrial and central venous pressure	48 hours
Need of catecholamines assessed with the inotropic score	48 hours
Urine output	48 hours

Trial Locations

Locations (1)

Children´s Heart Center Linz; 🇦🇹 Linz, Austria